Technology-assisted Case Management in Adults With Type 2 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/19/2018 |
| Start Date: | July 2011 |
| End Date: | June 2016 |
Effectiveness of Technology-Assisted Case Management in Low Income Adults With Type 2 Diabetes
The purpose of this study is to help low income patients achieve and maintain better
self-management skills and improve blood sugar levels, using a 2-in-1 blood glucose and blood
pressure monitoring system and nurse case management. Patients must be served at a Federally
Qualified Health Center (FQHC) in coastal South Carolina.
self-management skills and improve blood sugar levels, using a 2-in-1 blood glucose and blood
pressure monitoring system and nurse case management. Patients must be served at a Federally
Qualified Health Center (FQHC) in coastal South Carolina.
The long-term goal is to develop a practical and sustainable system of diabetes management
that will help low income patients achieve and maintain goals within established treatment
guidelines regardless of geographic location. This randomized clinical trial will employ the
innovative FORA system, an inexpensive, off-the-shelf, state-of-the-art technology comprised
of a 2-in-1 Blood Glucose and Blood Pressure monitor, coupled with nurse case management
(TACM) to optimize diabetes care for low income, rural adults with type 2 diabetes (T2DM).
The target population will be low income patients served in Federally Qualified Health Care
Centers (FQHCs) with poorly controlled T2DM residing in coastal South Carolina. Two hundred
patients will be randomly assigned to two groups of 100 patients each; Group A (Usual Care)
and Group B (Technology-assisted Case Management, TACM). Each patient will be followed for 6
months, with study visits at baseline, 3, and 6 months. The primary outcome will be
Hemoglobin A1c (HbA1c) at 6 months post-randomization while the secondary outcomes will be
blood pressure control and quality of life (qol) at 6 months post-randomization.
that will help low income patients achieve and maintain goals within established treatment
guidelines regardless of geographic location. This randomized clinical trial will employ the
innovative FORA system, an inexpensive, off-the-shelf, state-of-the-art technology comprised
of a 2-in-1 Blood Glucose and Blood Pressure monitor, coupled with nurse case management
(TACM) to optimize diabetes care for low income, rural adults with type 2 diabetes (T2DM).
The target population will be low income patients served in Federally Qualified Health Care
Centers (FQHCs) with poorly controlled T2DM residing in coastal South Carolina. Two hundred
patients will be randomly assigned to two groups of 100 patients each; Group A (Usual Care)
and Group B (Technology-assisted Case Management, TACM). Each patient will be followed for 6
months, with study visits at baseline, 3, and 6 months. The primary outcome will be
Hemoglobin A1c (HbA1c) at 6 months post-randomization while the secondary outcomes will be
blood pressure control and quality of life (qol) at 6 months post-randomization.
Inclusion Criteria:
- Age ≥18 years and receiving care within the Franklin C. Fetter Family Health Center
- Clinical diagnosis of T2DM and HbA1c ≥8% at the screening visit
- Subject must be willing to use the FORA 2-in-1 system
- Subject must have a working land-line for the duration of the study in order to be
able to upload the readings from the FORA 2-in-1 machine
- Subjects must be able to communicate in English
Exclusion Criteria:
- Mental confusion on interview suggesting significant dementia
- Participation in other diabetes clinical trials
- Alcohol or drug abuse/dependency using a screening questionnaire
- Active psychosis or acute mental disorder
- Life expectancy <6 months
- Pregnant and/or lactating females
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